HOUSTON, TX – Salarius Pharmaceuticals, Inc. (NASDAQ:SLRX) disclosed today a significant development regarding its clinical trial for the drug seclidemstat. The company, in a recent filing with the Securities and Exchange Commission (SEC), announced that a patient experienced a grade 4 adverse event during a clinical trial evaluating seclidemstat in combination with azacitidine.
The trial, conducted by The University of Texas MD Anderson Cancer Center (MDACC), was testing the drug's efficacy for adult patients with myelodysplastic syndromes and chronic myelomonocytic leukemia. Following the adverse event, reported to the company on Tuesday, the U.S. Food and Drug Administration (FDA) has placed the clinical trial on a partial clinical hold.
This decision prohibits the enrollment of new patients but allows those currently in the trial to continue their treatment if they are receiving benefits from the therapy.
Salarius Pharmaceuticals has committed to assisting MDACC researchers in analyzing the data from the trial and addressing questions from the FDA. The partial clinical hold is a precautionary measure to ensure patient safety while the company and MDACC work to understand the cause and implications of the adverse event.
The SEC filing did not provide specific details about the nature of the adverse event. Adverse events are graded on a scale from 1 to 5, with grade 4 being life-threatening or disabling. Such events are not uncommon in clinical trials, especially when investigating treatments for serious diseases, and they are an important part of assessing a drug's safety profile.
Salarius Pharmaceuticals is known for its focus on developing treatments for rare cancers. Seclidemstat, the drug at the center of this trial, is a key part of the company's pipeline and has been the subject of ongoing research.
The information in this article is based on a press release statement.
In other recent news, Salarius Pharmaceuticals, Inc. announced a reverse stock split to meet Nasdaq's minimum bid price requirement. The 1-for-8 split is set to take effect, decreasing the number of Salarius' issued and outstanding common stock shares from roughly 4.7 million to about 0.6 million. This move follows the approval from Salarius' stockholders, authorizing the Board of Directors to determine the appropriate split ratio within the range of 1-for-4 to 1-for-8.
The reverse split, aiming to boost Salarius' stock price, will be implemented uniformly for all stockholders, ensuring unchanged ownership percentages, except where fractional shares result in cash payouts.
Additionally, all outstanding options and warrants will be adjusted in accordance with the reverse split. Equiniti Trust Company, LLC, has been designated as the exchange agent and transfer agent for the reverse split process. These are recent developments reflecting the company's efforts to comply with Nasdaq's requirements.
InvestingPro Insights
In light of the recent developments at Salarius Pharmaceuticals, investors may be seeking a broader financial perspective on the company. According to InvestingPro data, Salarius Pharmaceuticals currently holds a market cap of $1.64 million and a price/book ratio of 0.45 for the last twelve months as of Q1 2024. Despite the challenges faced in the clinical trial, the company's stock showed a significant return over the last week with a 13.33% price total return.
InvestingPro Tips suggest that Salarius Pharmaceuticals holds more cash than debt on its balance sheet, which could provide some financial stability. However, the company is not expected to be profitable this year, with analysts anticipating a drop in net income. Moreover, the stock has struggled over the last month and six months, reflecting investor concerns and market reactions to the company's performance and recent news.
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